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RSS FeedPosted by Michael Wonder on 04 Oct 2016
US FDA grants breakthrough therapy designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC
4 October 2016 - This second Alecensa breakthrough therapy designation granted is based on phase 3 J-ALEX study. ...
Posted by Michael Wonder on 26 Sep 2016
AbbVie announces submission of a supplemental new drug application for Ibrutinib (imbruvica) for treatment of marginal zone lymphoma
26 September 2016 - If approved by the U.S. FDA, ibrutinib will be the first therapy specifically approved for patients with ...
Posted by Michael Wonder on 21 Sep 2016
Evaluating the FDA’s approach to cancer clinical trials
16 September 2016 - Since the announcement of the FDA Oncology Center of Excellence in June 2016 as part of the ...
Posted by Michael Wonder on 12 Sep 2016
Tesaro receives FDA fast track designation for niraparib and initiates rolling NDA submission
12 September 2016 - Tesaro today announced that the U.S. FDA has granted fast track designation to niraparib for the treatment ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 03 Sep 2016
FDA approves Blincyto (blinatumomab) for use In paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 September 2016 - Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) ...
Posted by Michael Wonder on 01 Sep 2016
ARIAD completes rolling submission of new drug application for brigatinib to the U.S. FDA
30 August 2016 - ARIAD Pharmaceuticals today announced it has completed the rolling submission of the new drug application for its ...
Posted by Michael Wonder on 01 Sep 2016
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL
31 August 2016 - Arzerra now approved by U.S. FDA for use in combination with fludarabine and cyclophosphamide in relapsed CLL ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 09 Aug 2016
Cancer-drug ads vs. cancer-drug reality
9 August 2016 - Two days into a long-dreamed-of family vacation to Italy in August 2013, my wife, Ronna, became nauseated, ...
Posted by Michael Wonder on 04 Aug 2016
More on FDA breakthrough therapies
4 August 2016 - The FDA has granted 148 breakthrough therapy designations as at 3 August 2016. Most of the ...
Posted by Michael Wonder on 03 Aug 2016
Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA breakthrough therapy designation as first-line treatment for HR+/HER2- advanced breast cancer
3 August 2016 - Designation underscores the continuing unmet need of the HR+/HER2- advanced breast cancer population and the potential of ...
Posted by Michael Wonder on 01 Aug 2016
MEI Pharma's pracinostat receives breakthrough therapy designation from FDA for treatment in combination with azacitidine of patients with newly diagnosed acute myeloid leukaemia unfit for intensive chemotherapy
1 August 2016 - MEI Pharma announced today that the U.S. FDA has granted breakthrough therapy designation for the investigational drug ...
Posted by Michael Wonder on 26 Jul 2016
Daratumumab receives breakthrough therapy designation from U.S. Food and Drug Administration in combination with standard of care regimens for previously treated multiple myeloma
26 July 2016 - Marks second breakthrough therapy designation for daratumumab. ...